Roche Diagnostics Operations, Inc. recalls Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Numbe
Recalled Product
Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determination of the albumin in human serum and plasma on Roche/Hitachi cobas c systems.
Hazard / Issue
Due to low Quality Control recovery and invalid Calibration.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: Lot # 33962301. Expanded on 12/20/19 to include lot 37437301
View official government recall
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